NSCLC (Advanced Non-small Cell Lung Cancer)NSCLC SCLCNCT07400575
Anlotinib in Cross-line Treatment of NSCLC and SCLC
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer) and SCLC, Extensive Stage, run by Henan Cancer Hospital.
Trial summary
Previous studies on bevacizumab in colorectal and ovarian cancers have demonstrated that continued anti-angiogenic therapy after disease progression can still provide clinical benefits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer), SCLC, Extensive Stage
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of patients with advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer who were driver gene-negative and had disease progression after anlotinib treatment.
Who may be able to join
- From October 1, 2018 to April 30, 2025, patients meeting all the following criteria will be included in this study:
- Patients must be diagnosed with advanced metastatic non-small cell lung cancer (including squamous cell carcinoma, adenocarcinoma, etc.) or extensive-stage small cell lung cancer during the period from October 1, 2018 to April 30, 2025.
- Patients clinically documented as having driver gene-negative advanced metastatic non-small cell lung cancer or extensive-stage small cell lung cancer, who were treated with anlotinib during the treatment period and continued using anlotinib after disease progression (with at least 4 months of continuous medication records in the medical records), or other immune or chemotherapy drugs.
- Patients who underwent at least one imaging examination within 90 days before reapplication of anlotinib or other immune or chemotherapy drugs after progression during anlotinib treatment, and subsequently had at least two imaging examinations.
Who cannot join
- From October 1, 2018 to April 30, 2025, patients meeting any of the following criteria will be excluded from this study:
- Patients who received other TKI-class anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) before the first application of anlotinib treatment.
- Patients who received other anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) after progression.
- Patients who underwent surgical treatment during anlotinib therapy. - Patients with driver gene positivity.
- Patients with concurrent other malignant tumors. - Pathological subtypes: advanced metastatic non-small cell lung cancer, including but not limited to large cell carcinoma, adenosquamous carcinoma, carcinoid, pulmonary sarcomatoid carcinoma; extensive-stage small cell lung cancer, including but not limited to oat cell type, mixed type, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicenter, Retrospective, Real World Study of Anlotinib in Cross-line Treatment of NSCLC and SCLC
Previous studies on bevacizumab in colorectal and ovarian cancers have demonstrated that continued anti-angiogenic therapy after disease progression can still provide clinical benefits. As a typical multi-targeted anti-angiogenic tyrosine kinase inhibitor, anlotinib hydrochloride has been approved in China for second-line or later treatment of advanced soft tissue sarcoma, where it has also shown significant potential. Retrospective studies have indicated the effectiveness of anlotinib in cross-line treatment for sarcoma. However, there is a lack of multi-center real-world studies evaluating the clinical efficacy of anlotinib in cross-line treatment for driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer.
This study aims to evaluate, through a retrospective multi-center study, the efficacy and safety of anlotinib monotherapy or combination regimens in the later-line treatment of driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer after anlotinib treatment failure, providing clinical evidence for cross-line therapy.
- Keywords
- Anlotinib, mNSCLC, ES-SCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Using Anlotinib in Cross-line Treatment of NSCLC and SCLC | |
| control group | Using Anlotinib in front-line treatment, but using an Anlotinib-free standard regimen in late-line treatment of NSCLC and SCLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: From first dose date of Anlotinib until the date of progression based on imaging assessment or date of death from any cause, whichever came first, assessed up to 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiming Wang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400575
- Sponsor's protocol ID
- 2025-631
- Acronym
- NSCLC SCLC
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Retrospective, Real World Study of Anlotinib in Cross-line Treatment of NSCLC and SCLC
- ClinicalTrials.gov ID
- NCT07400575
- Acronym / sponsor ID
- NSCLC SCLC / 2025-631
- Keywords
- Anlotinib, mNSCLC, ES-SCLC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies on bevacizumab in colorectal and ovarian cancers have demonstrated that continued anti-angiogenic therapy after disease progression can still provide clinical benefits. As a typical multi-targeted anti-angiogenic tyrosine kinase inhibitor, anlotinib hydrochloride has been approved in China for second-line or later treatment of advanced soft tissue sarcoma, where it has also shown significant potential. Retrospective studies have indicated the effectiveness of anlotinib in cross-line treatment for sarcoma. However, there is a lack of multi-center real-world studies evaluating the clinical efficacy of anlotinib in cross-line treatment for driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer.
This study aims to evaluate, through a retrospective multi-center study, the efficacy and safety of anlotinib monotherapy or combination regimens in the later-line treatment of driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer after anlotinib treatment failure, providing clinical evidence for cross-line therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | – | –Using Anlotinib in Cross-line Treatment of NSCLC and SCLC |
| control group | – | –Using Anlotinib in front-line treatment, but using an Anlotinib-free standard regimen in late-line treatment of NSCLC and SCLC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients with advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer who were driver gene-negative and had disease progression after anlotinib treatment.
Key inclusion criteria (4 listed)
- From October 1, 2018 to April 30, 2025, patients meeting all the following criteria will be included in this study:
- Patients must be diagnosed with advanced metastatic non-small cell lung cancer (including squamous cell carcinoma, adenocarcinoma, etc.) or extensive-stage small cell lung cancer during the period from October 1, 2018 to April 30, 2025.
- Patients clinically documented as having driver gene-negative advanced metastatic non-small cell lung cancer or extensive-stage small cell lung cancer, who were treated with anlotinib during the treatment period and continued using anlotinib after disease progression (with at least 4 months of continuous medication records in the medical records), or other immune or chemotherapy drugs.
- Patients who underwent at least one imaging examination within 90 days before reapplication of anlotinib or other immune or chemotherapy drugs after progression during anlotinib treatment, and subsequently had at least two imaging examinations.
Key exclusion criteria (5 listed)
- From October 1, 2018 to April 30, 2025, patients meeting any of the following criteria will be excluded from this study:
- Patients who received other TKI-class anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) before the first application of anlotinib treatment.
- Patients who received other anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) after progression.
- Patients who underwent surgical treatment during anlotinib therapy. - Patients with driver gene positivity.
- Patients with concurrent other malignant tumors. - Pathological subtypes: advanced metastatic non-small cell lung cancer, including but not limited to large cell carcinoma, adenosquamous carcinoma, carcinoid, pulmonary sarcomatoid carcinoma; extensive-stage small cell lung cancer, including but not limited to oat cell type, mixed type, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS
Time frame: From first dose date of Anlotinib until the date of progression based on imaging assessment or date of death from any cause, whichever came first, assessed up to 84 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer) and SCLC, Extensive Stage, run by Henan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiming Wang (13783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From first dose date of Anlotinib until the date of progression based on imaging assessment or date of death from any cause, whichever came first, assessed up to 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.